FY 2019 HOSPITAL CODING AND PAYMENT GUIDE

Transcription

1 FY 2019 HOSPITAL CODING AND PAYMENT GUIDE MitraClip Transcatheter Mitral Valve Repair Effective October 1, 2018 Indication for Use: The MitraClip System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

2 MITRACLIP TRANSCATHETER MITRAL VALVE REPAIR FY 2019 Hospital Coding and Payment Guide Policy Update Effective for dates of service beginning October 1, 2016, the Centers for Medicare and Medicaid Services (CMS) has assigned transcatheter mitral valve repair (TMVr) procedures to MS-DRGs Other Cardiothroacic Procedures with and without MCCs, respectively. For fiscal year 2019, these MS-DRG assignments remain unchanged. The Centers for Medicare and Medicaid Services (CMS) provide coverage for transcatheter mitral valve repair (TMVr) under Coverage with Evidence Development. 1 Among the coverage criteria specified in this National Coverage Determination (NCD): TMVr must be performed by an interventional cardiologist or a cardiothoracic surgeon. Interventional cardiologist(s) and cardiothoracic surgeon(s) may jointly participate in the intraoperative technical aspects of TMVr as appropriate. Note that local Medicare Administrative Contractors (MACs) may have additional coverage criteria as published in Local Coverage Determinations or articles. Additional Information Abbott is committed to supporting appropriate patient access to the MitraClip therapy and educating providers on the latest coverage, coding and payment policy. For additional questions, please contact the Reimbursement Hotline: Questions@AskAbbottVascular.com All TMVr cases must be enrolled in the national transcatheter valve therapy (TVT) registry. Other institutional and operator requirements apply based on multisociety guidelines. Refer to the NCD Decision Memo and MLN Matters Number MM9002 for additional details and requirements. 2

3 PAGE 1 PAGE 2 PAGE 3 MITRACLIP TRANSCATHETER MITRAL VALVE REPAIR Procedure Codes ICD-10-PCS PROCEDURE CODE 02UG3JZ B245ZZ4 DESCRIPTOR Supplement mitral valve with Synthetic Substitute, Percutaneous approach Ultrasonography of Left Heart, Transesophageal For other concomitant conditions, other TEE codes may apply. Diagnostic cardiac catheterization may also be coded when it is performed for specific evaluation beyond the approach to the procedure. If the cardiac catheterization is part of the approach for the procedure, it may not be coded separately. 3 Diagnosis Codes Below are the ICD-10-CM codes currently included in the NCD for TMVr. 2 It is the responsibility of the hospital and physician to determine the appropriate diagnosis code(s) for each patient. As discussed above, participation in the TVT Registry is a requirement of TMVr coverage. Secondary ICD- 10-CM Diagnosis Code Z00.6 should be used to denote clinical trial participation for these TMVr claims. 2 ICD-10-PCS PROCEDURE CODE DESCRIPTOR Nonrheumatic mitral (valve) insufficiency Nonrheumatic mitral valve prolapse 4 Zoo.6 Encounter for exam for normal comparison and control in clinical research program

4 PAGE 1 PAGE 2 PAGE 3 MITRACLIP TRANSCATHETER MITRAL VALVE REPAIR Additional Requirements Additional coding requirements are necessary for TMVr cases enrolled in the TVT Registry ADDITIONAL REQUIRED INFORMATION NOTES NCT National Clinical Trial Number is required for cases enrolled in the TVT Registry. 2 Condition Code 30 Condition Code is required for cases enrolled in the TVT Registry. 2

5 PAGE 1 PAGE 2 PAGE 3 MITRACLIP TRANSCATHETER MITRAL VALVE REPAIR Hospital Claim Checklist: The following is a checklist of information that is required to process claims for TMVr procedures with the MitraClip System per CMS s NCD. It is the responsibility of the hospital or physician to determine appropriate coding for a particular patient and/or procedure. Any claim should be coded appropriately and supported with adequate documentation in the medical record. CODES / MODIFIERS / OTHER WHEN USED? INCLUDED NA DIAGNOSIS CODES I34.0: Nonrheumatic mitral (valve) insufficiency When appropriate 134.1: Nonrheumatic mitral valve prolapse All cases Zoo.6: Encounter for exam for normal comparison and control in clinical research program All cases PROCEDURE CODE 02UG3JZ: Supplement mitral valve with Synthetic Substitute, Percutaneous approach B245ZZ4: Ultrasonography of Left Heart, Transesophageal All cases All cases CONDITION CODE Condition Code 30 All cases NCT NUMBER All cases* *NCT number is required for cases enrolled in the TVT registry. There is a separate NCT number for the ongoing Investigational Device Exemption (IDE) trial using MitraClip therapy called the COAPT trial. For coding and billing instructions for MitraClip procedures that are part of this trial please contact the Reimbursement Hotline.

6 MITRACLIP TRANSCATHETER MITRAL VALVE REPAIR Hospital Inpatient Payment: Medicare inpatient payments below are effective for FY 2019; October 1, 2018 through September 30, Effective October 1, 2016 CMS has assigned TMVr procedures to MS-DRGs , Other cardiothoracic procedures, with and without MCCs, respectively. MS-DRG DESCRIPTOR FY 2019 NATIONAL BASE PAYMENT Other cardiothoracic procedures with MCC $40, Other cardiothoracic procedures without MCC $28,398 Note that actual hospital payment will vary based on adjustments for factors including geographic differences, teaching status, and disproportionate share of indigent patients. Private Payers Private payers use a variety of payment methods for reimbursing inpatient services including case rates, percent of billed charges, DRGs, and device carve outs. Please check with your payer regarding appropriate coding and payment information.

7 PAGE 1 PAGE 2 PAGE 3 PAGE 4 MITRACLIP CLIP DELIVERY SYSTEMS INDICATIONS FOR USE The MitraClip System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation. CONTRAINDICATIONS The MitraClip System is contraindicated in DMR patients with the following conditions: Patients who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen Active endocarditis of the mitral valve Rheumatic mitral valve disease Evidence of intracardiac, inferior vena cava (IVC) or femoral venous thrombus WARNINGS DO NOT use MitraClip NT outside of the labeled indication. Treatment of non-prohibitive risk DMR patients should be conducted in accordance with standard hospital practices for surgical repair and replacement. MitraClip is intended to reduce mitral regurgitation. The MitraClip procedure is recommended to be performed when an experienced heart team has determined that reduction of MR to 2+ is reasonably expected following the MitraClip. If MR reduction to 2+ is not achieved, the benefits of reduced symptoms and hospitalizations, improved quality of life, and reverse LV remodeling expected from MitraClip may not occur. The MitraClip Implant should be implanted with sterile techniques using fluoroscopy and echocardiography (e.g., transesophageal [TEE] and transthoracic [TTE]) in a facility with on-site cardiac surgery and immediate access to a cardiac operating room. Read all instructions carefully. Failure to follow these instructions, warnings and precautions may lead to device damage, user injury or patient injury. Use universal precautions for biohazards and sharps while handling the MitraClip System to avoid user injury. Use of the MitraClip should be restricted to those physicians trained to perform invasive endovascular and transseptal procedures and those trained in the proper use of the system. The Clip Delivery System is provided sterile and designed for single use only. Cleaning, re-sterilization and / or reuse may result in infections, malfunction of the device or other serious injury or death.

8 PAGE 1 PAGE 2 PAGE 3 PAGE 4 MITRACLIP CLIP DELIVERY SYSTEMS PRECAUTIONS Patient Selection: - Prohibitive risk is determined by the clinical judgment of a heart team, including a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, due to the presence of one or more of the following documented surgical risk factors: 30-day STS predicted operative mortality risk score of 8% for patients deemed likely to undergo mitral valve replacement or 6% for patients deemed likely to undergo mitral valve repair Porcelain aorta or extensively calcified ascending aorta. Frailty (assessed by in-person cardiac surgeon consultation) Hostile chest Severe liver disease/cirrhosis (MELD Score >12) Severe pulmonary hypertension (systolic pulmonary artery pressure >2/3 systemic pressure Unusual extenuating circumstance, such as right ventricular dysfunction with severe tricuspid regurgitation, chemotherapy for malignancy, major bleeding diathesis, immobility, AIDS, severe dementia, high risk of aspiration, internal mammary artery (IMA) at high risk of injury, etc. Evaluable data regarding safety or effectiveness is not available for prohibitive risk DMR patients with an LVEF < 20% or an LVESD > 60mm. MitraClip should be used only when criteria for clip suitability for DMR have been met. The major clinical benefits of MitraClip are reduction of MR to 2+ resulting in reduced hospitalizations, improved quality of life, reverse LV remodeling and symptomatic relief in patients who have no other therapeutic option. No mortality benefit following MitraClip therapy has been demonstrated. The heart team should include a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease and may also include appropriate physicians to assess the adequacy of heart failure treatment and valvular anatomy. The heart team may determine an in-person surgical consult is needed to complete the assessment of prohibitive risk. The experienced mitral valve surgeon and heart team should take into account the outcome of this surgical consult when making the final determination of patient risk status. For reasonable assurance of device effectiveness, pre-procedural evaluation of the mitral valve and underlying pathologic anatomy and procedural echocardiographic assessment are essential. Note the Use by date specified on the package. Inspect all product prior to use. Do not use if the package is open or damaged, or if product is damaged.

9 PAGE 1 PAGE 2 PAGE 3 PAGE 4 MITRACLIP CLIP DELIVERY SYSTEMS SPECIAL PATIENT POPULATIONS Mitral Valve Etiology Safety and effectiveness of the MitraClip device has not been established in patients with MR due to underlying ventricular pathology (functional mitral regurgitation or FMR). Pregnancy The MitraClip device has not been tested in pregnant women. Effects on the developing fetus have not been studied. The risks and reproductive effects are unknown at this time. Gender No safety or effectiveness related gender differences were observed in clinical studies. Ethnicity Insufficient subject numbers prevent ethnicity-related analyses on the clinical safety and effectiveness. Anatomic Considerations For optimal results, the following anatomic patient characteristics should be considered. The safety and effectiveness of the MitraClip outside of these conditions has not been established. Use outside these conditions may interfere with placement of the MitraClip Implant or mitral valve leaflet insertion. - The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant - Mitral valve area 4.0 cm2 - Minimal calcification in the grasping area - No leaflet cleft in the grasping area - Flail width < 15 mm and flail gap < 10 mm Pediatrics Safety and effectiveness of the MitraClip device has not been established in pediatric patients.

10 PAGE 1 PAGE 2 PAGE 3 PAGE 4 MITRACLIP CLIP DELIVERY SYSTEMS POTENTIAL COMPLICATIONS AND ADVERSE EVENTS The following ANTICIPATED EVENTS have been identified as possible complications of the MitraClip procedure. Allergic reaction (anesthetic, contrast, Heparin, nickel alloy, latex); Aneurysm or pseudo-aneurysm; Arrhythmias; Atrial fibrillation; Atrial septal defect requiring intervention; Arterio-venous fistula; Bleeding; Cardiac arrest; Cardiac perforation; Cardiac tamponade / Pericardial Effusion; Chordal entanglement / rupture; Coagulopathy; Conversion to standard valve surgery; Death; Deep venous thrombus (DVT); Dislodgement of previously implanted devices; Dizziness; Drug reaction to anti-platelet / anticoagulation agents / contrast media; Dyskinesia; Dyspnea; Edema; Emboli (air, thrombus, MitraClip Implant); Emergency cardiac surgery; Endocarditis; Esophageal irritation; Esophageal perforation or stricture; Failure to deliver MitraClip to the intended site; Failure to retrieve MitraClip System components; Fever or hyperthermia; Gastrointestinal bleeding or infarct; Hematoma; Hemolysis; Hemorrhage requiring transfusion; Hypotension / hypertension; Infection; Injury to mitral valve complicating or preventing later surgical repair; Lymphatic complications; Mesenteric ischemia; MitraClip Implanterosion, migration or malposition; MitraClip Implant thrombosis; MitraClip System component(s) embolization; Mitral stenosis; Mitral valve injury; Multi-system organ failure; Myocardial infarction; Nausea / vomiting; Pain; Peripheral ischemia; Prolonged angina; Prolonged ventilation; Pulmonary congestion; Pulmonary thrombo-embolism; Renal insufficiency or failure; Respiratory failure / atelectasis / insufficiency or failure; Respiratory failure / atelectasis / pneumonia; Septicemia; Shock, Anaphylactic or Cardiogenic; Single leaflet device attachment (SLDA); Skin injury or tissue changes due to exposure to ionizing radiation; Stroke or transient ischemic attack (TIA); Urinary tract infection; Vascular trauma, dissection or occlusion; Vessel spasm; Vessel perforation or laceration; Worsening heart failure; Worsening mitral regurgitation; Wound dehiscence

11 Disclaimer The information provided in this document was obtained from third-party sources and is subject to change without notice as a result of changes in reimbursement laws, regulations, rules, policies, and payment amounts. All content is informational only, general in nature, and does not cover all situations or all payers rules and policies. It is the responsibility of the hospital or physician to determine appropriate coding for a particular patient and/or procedure. Any claim should be coded appropriately and supported with adequate documentation in the medical record. A determination of medical necessity is a prerequisite that Abbott assumes will have been made prior to assigning codes or requesting payments. Any codes provided are examples of codes that specify some procedures or which are otherwise supported by prevailing coding practices. They are not necessarily correct coding for any specific procedure using Abbott products. Hospitals and physicians should consult with appropriate payers, including Medicare Administrative Contractors, for specific information on proper coding, billing, and payment levels for healthcare procedures. Abbott makes no express or implied warranty or guarantee that (i) this list of codes and narratives is complete or error-free in this document, (ii) the use of this information will prevent difference of opinions or disputes with payers, (iii) these codes will be covered or (iv) the provider will receive the reimbursement amounts set forth herein. Reimbursement policies can vary considerably from one region to another and may change over time. The FDA-approved/ cleared labeling for all products may not be consistent with all uses described herein. This document is in no way intended to promote the off-label use of medical devices. This content is not intended to instruct hospitals and/or physicians on how to use medical devices or bill for healthcare procedures. References 1. CMS National Coverage Determination for Transcatheter Mitral Valve Repair CMS MLN Matters MM9002 Transcatheter Mitral Valve Repair (TMVR)-National Coverage Determination (NCD) 3. AHA Coding Clinic, Third Quarter, 2004, page Per CMS Transmittal 1630, released February 26, Centers for Medicare & Medicaid Services 42 CFR Parts 412, 413, 424, and 495 [CMS-1694-F] RIN 0938-AT27 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and LongTerm Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available), at eifu.abbottvascular.com or at Manuals.sjm.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events Abbott 3200 Lakeside Dr., Santa Clara, CA USA Tel: MitraClip is a trademark of the Abbott Group of Companies Abbott. All rights reserved. AP US-Rev M